Techniques to Reduce the Severity and Frequency of Emergent Reactions
- Conditions
- Analgesia
- Interventions
- Behavioral: Do we speak to them in a way that convinces them to have the dreamBehavioral: Speaking to them as a regualar person
- Registration Number
- NCT03832309
- Lead Sponsor
- CHRISTUS Health
- Brief Summary
The objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. Second, to determine if people dream about what they were thinking about when they were induced with ketamine.
- Detailed Description
The proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department.
The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital. CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in south Texas. It is a major teaching affiliate of Texas A\&M medical school, and serves an inner-city population.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
- Be at least 18 years of age
- Required need for procedural sedation and analgesia
- Age< 18
- Hypertension
- Raised Intracranial pressure
- Major psychological disorders
- Procedures involving laryngel manipulations
- History of Laryngeal sapsm History of adverse reactions to ketamine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Do we speak to them in a way that convinces them to have the dream Half of the participants will receive the sedation medication with the usual conversation while the physician is giving the medication to the patient. The other half of the participants will have a more positive conversation, (which is the study intervention), with the physician while being given the medication. Both group's emergence reactions, if any, will be compared to see if the positive conversation reduced the side effect. Group 1 Do we speak to them in a way that convinces them to have the dream Packet 1: The Physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel no pain, cause them to forget the procedure, and allow them to dream the dream of their choice. Control Arm Speaking to them as a regualar person Half of the participants will receive the sedation medication with the usual conversation while the physician is giving the medication to the patient. The other half of the participants will have a more positive conversation, (which is the study intervention), with the physician while being given the medication. Both group's emergence reactions, if any, will be compared to see if the positive conversation reduced the side effect. Group 1 Speaking to them as a regualar person Packet 1: The Physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel no pain, cause them to forget the procedure, and allow them to dream the dream of their choice.
- Primary Outcome Measures
Name Time Method STAI-6 24 months To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information.
T-Test 24 months Data gathered from post sedation questionnaire, specifically question 5, will be analyzed by comparing the two means of group one and group two using a student's T test,
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHRISTUS Health
🇺🇸Corpus Christi, Texas, United States